Spectranetics Bridge Occlusion Balloon catheter — Class I medical device recall Z-3106-2017
Terminated recall by Spectranetics Corporation, reported 2017-10-04, distributed nationwide. Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay
| Recall number | Z-3106-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectranetics Corporation, Colorado Springs, CO, United States |
| Recall initiated | 2017-08-07 |
| Classified | 2017-09-22 |
| Reported by FDA | 2017-10-04 |
| Terminated | 2020-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CY, DE, DK, FI, FR, GB, HU, IE, IL, IS, IT, KW, NL, NO, PL, SE, ZA |
| Quantity | 2,356 units |
| Lot numbers | FMN17B13A, FMN17C08A, FMN17C28A, FMN17D07A, FMN17D19A, FMN17D27A, FMN17E02A, FMN17E23A, FMN17E31A, FMN17E31B, FMN17F06A, FMN17F20A, FMN17F21A, FMN17G12A, FMN17G18A, FMN17H03A, FMN17H04A, FMN17H05A, FMN17H10A, FMN17H12A, FMN17H15A, FMN17H17A, FMN17H29A, FMN17J28A, FMN17K02A, FMN47D12A |
| Model numbers | 590-001, FMN17B13A, FMN17C08A, FMN17C28A, FMN17D07A, FMN17D19A, FMN17D27A, FMN17E02A, FMN17E23A, FMN17E31A, FMN17E31B, FMN17F06A, FMN17F20A, FMN17F21A, FMN17G12A, FMN17G18A, FMN47D12A |
Product
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.
Reason for recall
Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3106-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.